Quality Control - Supervisor (Project Coodinators)

  The Quality Control Supervisor, under general direction, will be responsible for implementing and maintaining a Quality Control Project Coordinator program that will encompass the needs of the client and of the internal departments for each program. The position will require frequent communication with the Chemistry, Cell Biology, Microbiology, Manufacturing, Process Science, Product Development, Quality Assurance, and vendor contacts to coordinate document generation, execution of testing, deviation management, change controls, an issuance of project/program deliverables.  Close attention to detail is required to oversee and compile the testing and data, to facilitate meeting deadlines and milestones.  Other responsibilities may include but are not limited to ownership of CAPA's and deviations, change controls, client meetings, attending planning meetings, communication of changes and utilizing new software.

External US

Essential Functions

• Follow Standard Operating Procedures (SOP's), other related Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP), and other site procedure documents (such as Chemical Hygiene Plan, SDS sheets)
• Assists in preparing QC metrics on a monthly basis and evaluating metrics for process improvements
• Assists in generating and approving PO's for external testing
• Work directly with contract laboratories to coordinate and monitor testing and release schedules. Provide point of escalation for any issues
• Work directly with customers to update and confirm schedules and deadlines, and to provide technical suggestions based on industry guidelines. Provide point of escalation for any issues
• Conduct training and mentoring of team members (existing and new)
• Communicates status of tasks to manager and other appropriate staff as required
• Oversee implementation and progress of objectives created by senior/upper management
• Lead implementation and track progress of group projects
• Performs deviation management for Quality Control Project Coordinator group, including identifying preventative and corrective actions
• Identify process improvements and assist in implementation of improvements
• Establish, review, and update GMP documentation as needed
• Ensuring all needed samples are entered in to site LIMS (ex. SmartQC)
• Organizes schedules and supervises resources for the team to support site operations
• Lead team and department meetings
• Interface with current and potential clients as well as interfaces with investigators during internal and external inspections/audits
• Open and track necessary change controls
• Supervise and lead QC Project Coordinator staff, including hiring, firing, coaching, mentoring, and performance management functions.
• Ability to work cross functionally with other Quality Control groups, Quality Assurance, Manufacturing, and Project management to meet project and program timelines
• Perform other duties as assigned

 

 

 

Required Skills & Abilities

• Computer proficiency required (Microsoft Office including Word and Excel)
• Excellent attention to detail
• Ability to provide and receive constructive feedback
• Ability to oversee employees, delegate roles and responsibilities appropriately, and provide support where needed
• Ability to multi-task and prioritize work assignments
• Ability to maintain detailed tracking and documentation clearly and accurately according to SOP's
• Excellent written and oral communication skills
• Ability to build and foster relationships, cooperation and collaboration across the team and the organization
• Ability to work in a team or independent setting and collaborate with various departments
• Ability to evolve and adapt to new technologies to include electronic planning tools and laboratory information management systems (LIMS)
• On-site attendance

 

Working Conditions & Physical Requirements The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to

• Experience prolonged standing, some bending, stooping, and stretching
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopies, telephone, calculator, and other office equipment as required
• Ability to sit for long periods to work on a computer
• Ability to wear personal protective equipment including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required in lab areas
• Attendance is mandatory

Minimum Qualifications

• High School Diploma or GED and minimum of ten (10) years of experience, with three (3) years in GxP setting;
• Associates degree and a minimum of eight (8) years of experience, with three (3) years in GxP setting;
• Bachelor's degree and a minimum of five (5) years of experience, with three (3) years in GxP setting;
• Master's degree and a minimum of three (3) years of experience in GxP setting.
• Two (2) years of experience in a supervisory or lead role.
• Previous customer interaction training or equivalent experience.

 

Preferred Qualifications

• Bachelor's degree in a scientific discipline
• Client relations background
• Analytical background
• Familiarity with Trackwise and SmartQC software
• Experience with GMP/GLP
• Lean Six Sigma training or similar process improvement training

 

 

We are an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. 

 

If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3500.